The Japanese healthcare is getting more and more challenging one because budgetary constraint policies require a balance to be found between the demand for public Medicare service and the healthcare cost. These challenges have recently become increasingly acute because of the heightened sense of uncertainty surrounding the Japanese economy which will be influenced by fluctuations in the global economy resulting from the price hike of crude oil, environmental issues, and the subprime loan crisis.
For radiological system industries, the year 2007 was severe. According to a survey conducted by the Japan Industries Association of Radiological Systems (JIRA), the domestic market, after showing solid growth for several years, started to decline in the first half of 2007, dropping to 85% in total when compared with the same period in 2006. The market has shrunk for X-ray, CT, MRI and ultrasound systems as well as nuclear medicine devices and associated equipment, while sales have slightly increased for therapy devices and other medical image processing equipment. Changes in the healthcare environment, including the revision of medical treatment fees and the uneven distribution and increased burden on medical staff, has affected the operation of many Japanese medical institutions which do not seem to have enough in reserve to invest in updating or expanding their equipment and systems. According to the survey by JIRA, the equipment replacement cycle in medical institutions exceeds 10 years on average, so the significance of ensuring the safety and maintenance of equipment has become ever more important. Such circumstances have cast a shadow over the promotion of state-of-the-art medical radiological systems which contribute to the improvement of healthcare to the public.
In 2007, the Japanese government announced a long-term strategy named “Innovation 25” to cope with the innovation within social systems and technical improvements. This strategy specified research and development into diagnostic or therapeutic machines for the enhancement of patient QOL as one of the prioritized science and technology areas with the goal of achieving “long and healthy lives.” Medical imaging systems play a major role in fostering desirable medical innovation in order to provide a safe and reliable healthcare for all whose realization is founded on cooperation and understanding among administrative, academic and industrial bodies.
JIRA aims at providing a medical system in which patients can return to social life safer and sooner with less invasive procedures to be achieved by upgrading medical imaging systems through advanced technology, image applications for preventive purposes, diagnosis, therapeutic initiatives and goals, as well as integration of medical information. JIRA intends to be active in devoting research and development efforts by linking medicine with engineering and continuing to offer state-of-the-art medical imaging systems.
On the other hand, there are many problems in developing and promoting these medical imaging systems. For example, the value of the systems has not appreciated properly and few incentives are available for development and clinical use of safer and more effective medical imaging systems due to the medical service fee system. Early detection and treatment of diseases is important in healthcare. To that end, preventive screening tests and initial diagnosis supported by essential medical imaging tools are critical components of effective health care. JIRA intends to solve these problems by cooperating with related academic and industrial bodies with the viewpoint of patients paramount, and by making practical proposals to administrative authorities.
To cope with the remarkable change in our business circumstances, we have devised a major action plan for 2008 in order to promote the following activities with cooperation between member companies.
1. Activities and proposals for appropriate evaluation of “medical imaging equipment which contribute to innovation in healthcare”.
For many years, JIRA has proposed undertaking an appropriate evaluation of medical imaging equipment however it has not sufficiently sparked up discussions about the evaluation system. So we launched a “bridge project” for the appropriate evaluation of medical imaging equipment about a year ago. Medical imaging equipment offers not only value for “patients and their families” and “doctors and their institutions” but also “innovations in healthcare”, which contribute to the maintenance of public health and the continuing fiscal health of medical insurance. From this standpoint, we make the following three proposals.
1) Reassurance and the appropriate evaluation of the value of medical imaging equipment.
Diagnostic imaging plays major role in early detection and treatment in various ways through tiered diagnosis including “checkups” for healthy subjects as well as “initial diagnosis” and “detailed diagnosis” for patients. Sufficient diagnosis and appropriate treatment will lead to efficient healthcare. We therefore propose that reassurance and appropriate evaluation of the value of medical imaging equipment should be implemented.
2) Evaluation of advanced equipment
In order to promote innovation in healthcare, a cycle needs to be established for the development of more advanced equipment and associated technologies and then active application and dissemination of the developed capable technologies. To that end, we will promote the utilization of appropriate systems as well as the evaluation of advanced equipment and technologies.
3) Maintenance management of medical imaging devices and significance of IT
Medical imaging equipment must be able to be used safely and exercise its performance to the full. Maintenance for these purposes has become more and more important as medical systems become increasingly sophisticated. Additionally, software including image processing which determines a good part of the performance of medical imaging systems has also become important. We therefore propose the clear positioning and evaluation of maintenance and software.
2. Proposal and cooperation toward the“5-year Strategy for the Creation of Innovative Pharmaceutical and Medical Devices”
The government of Japan endorsed the “Innovation 25” in June, last year. In the “Basic Policies for Economic and Fiscal Management and Structural Reform 2007,” the government clearly stated its desire to push the basic policies of “Innovation 25.”The basic policies include a “Five-Year Strategy for Creation of Innovative Medical Devices” (the “Five-Year Strategy”), issued by the Ministry of Education, Culture, Sports, Science and Technology; the Ministry of Health, Labour and Welfare; and the Ministry of Economy, Trade and Industry. These three ministries will work together to tackle the following issues. 1) Intensive spending in R&D 2) Promote start-ups 3) Improve clinical trials and clinical research environment 4) Promote partnerships with Asia 5) Accelerate and make improved reviews of new drugs 6) Evaluate innovations properly. The Five-Year Strategy includes separate plans for pharmaceutical and medical devices. JIRA intends to make active proposals, from the point of view of medical equipment especially medical imaging equipment, for the medical institutional problems including promotion of medical equipment R&D, acceleration of reviews, provision of incentives by promoting appropriate evaluation, international integrity of standardization and human resource development. Furthermore, we will create a clinical environment in which advanced medical imaging equipment can be used sooner. JIRA has sent some members to the “Five-Year Strategy Promotion WG” which was established within the Japan Federation of Medical Devices Associations, in order to strengthen cooperation with other related organizations, make proposals for administrative bodies and respond to such policies. For further promotion of such activities, we have newly established the “JIRA 5-year Strategy WG.”
3. Proposal and cooperation toward “The New Vision of Medical Device and Medical Technology Industries”
“The Vision for Medical Device Industries” started in 2003, ended in 2007. The Ministry of Health, Labour and Welfare has launched “The New Vision for Medical Devices and Medical Technology Industries” which will look forward to the next 10 years. The new vision will divide medical equipment into two areas; “innovative” and “improved” medical equipment at the same time as creating diagnosis and treatment sections. The vision presented will be based on the characteristics and challenges of each section with a new vision being created for the technology fusion section. Based on these visions, action plans will be developed for the enhancement of international competitiveness based on principles of “the new health frontier strategy” and “the five-year strategy.” Based on the development of this new vision, JIRA has made the following three proposals.
1) Creation of discussion opportunities with related government ministries and agencies and gathering opinions on matters including the framework and handling requirements for assurance of the high quality, efficiency, and safety of clinical application software used in diagnostic imaging.
2) Clarifying of rationale for the appropriate evaluation of the clinical effects of medical imaging equipment.
3) Implementation of comprehensive policy corresponding to the increased sophistication of equipment such as “from morphological imaging diagnosis to functional imaging diagnosis”
We intend to make further proposals and provide an impetus so that the policies on medical imaging systems will reflect our proposals.
4. Promotion of engagement for the “safety and reliability” of medical equipment
JIRA has responded to the problems that have occurred as a consequence of the revision of the Pharmaceutical Affairs Law in April, 2005, by making proposals through regular meetings with administrative agencies as well as participating in the “working-level joint task force on medical devices.” However, the medical law was also revised as part of the 5th phase of the healthcare reforms in April, 2007. The revised medical law emphasized improvements in the safety and quality of medical institutions, which will require further engagement of the “safety and reliability” aspects of medical equipment than ever before. Given this situation, JIRA intends to promote the following four activities.
1) We propose the equipment dispatch guidelines should include the standardization of information which is required to be offered by suppliers for education in a pre-fixed period. We will also request that the guidelines include more items. We are devoted to improving the equipment dispatch guidelines and the public relations function of the guidelines.
2) We intend to create a preventive maintenance environment by setting in place “routine inspection”, which is vital for the safe and essential operation of medical equipment as well as providing clients with information about failure prediction and likely replacement parts based on routine check data and history of past cases.
3) The information service on medical imaging systems has become diversified. For appropriate information provision to medical institutions, we intend to give consideration to the required characteristics of the person in charge of medical equipment information, how to use the data effectively, and how we should respond to the computerization of information.
4) We engage in support activities for medical institutions devoted to maintaining “the safe and reliable” provision of medical equipment, for example, by the promotion of routine inspections including checks at opening and closing times which contribute to developing a safe management climate as well as the provision of information needed for the enhancement and improvement of operational quality. We are also actively involved in public relations surrounding such activities so that medical institutions can take full advantage of this information.
Through the four activities above, JIRA make efforts to ensure “safety and reliability” of medical equipment.
5. Enhancement of international activity
In cooperation with foreign industrial associations (Europe: COCIR, U.S.: NEMA, China: CAMDI, Korea: KMDICA), JIRA will perform various international activities, including the trade of medical devices, reimbursement, international standardization and international harmonization, thus promoting JIRA’s presence. It will survey the laws and regulations regarding medical devices in growing Asian markets, especially China and Korea, and provide information for members.
In 2007, JIRA took part in three exhibitions taking place in China, namely CHINA-HOSPEQ and China International Medical Equipment Fair (CMEF) Spring and Autumn. In the exhibitions, we introduced JIRA’s activities and displayed the associated equipment of member companies. This year, we will continue to focus on China and Korea to promote the presence of JIRA and support member companies.
As regards DITTA held in the period of RSNA2007, which consists of three associations; COCIR, NEMA, and JIRA, we discussed market trends and the various regulations of medical devices from a global standpoint. JIRA will continue to play an active role in the Asian region, while promoting international harmonization with DITTA members.
JIRA is also a member of the Global Harmonization Task Force (GHTF) to promote harmonization of regulations and offer support to developing countries regarding medical equipment regulations. Recently, we have joined the Asian Harmonization Working Party (AHWP).
6. Promotion of close cooperation with associated organizations
JIRA will promote exchange and cooperation with medical associations: the Japan Radiological Society (JRS), Japanese Society of Radiological Technology (JRST), Japanese Federation of Medical Devices Associations (JFMDA), Japan Electronics and Information Technology Industries Association (JEITA), and Japanese Association of Healthcare Information Systems Industry (JAHIS), etc. JIRA will submit proposals about reimbursement and laws related to medical equipment as well as policies including “The Five-year Strategy for the Creation of Innovative Pharmaceutical and Medical Devices” and “The New Vision of Medical Device and Medical Technology Industries” to governmental agencies, the Cabinet Office, the Ministry of Health, Labour and Welfare, the Ministry of Economy, Trade and Industry, and the Ministry of Education, Culture, Sports, Science and Technology. In addition, JIRA will promote public relations activity through its web site and publications such as“Associated Industries of Diagnostic Imaging Equipment 2008” and “Technical Report” as well as various guidelines.
7. Compliance implementation
In an era of significant change, compliance is the backbone for business activities. Under the slogan “ compliance will protect you”, we will ensure our member companies abide by the “Code of Ethical Practice”, “JIRA Compliance Declaration”, “Guidelines for promotion code” and “Medical device fair competition codes” in order to promote fair and orderly business activities. We will particularly emphasize fair trade and continue our efforts to make JIRA members more conscious that fair and free trade is required with a high level of transparency. We also conduct publicity activities aimed at medical institutions and medical service workers.
8. Reinforcement of cooperation between member companies and development of JIRA services to members
To cope with remarkable change in our business circumstances, JIRA is required to be more global and speedy in its activities. In 2008, we will reinforce cooperation between member companies towards new activities to realize visions specified in “the bridge project for the appropriate evaluation of medical imaging devices.” We will also strengthen our IT infrastructure and its operation. These activities will reinforce the foundation of various activities including improving JIRA services to members. Our main services to members include “continued training,” “JIRA market statistics” and “exhibition operations.”
In 2006, the revised PAL imposed “continual training”. JIRA cooperated with three other bodies and held training courses nine times at seven sites, which 1,574 trainees completed. JIRA will continue training courses mainly for member companies.
In April 2006, we introduced “JIRA market statistics” into the statistics system to make it more accurate and useful for member companies. We intend to further improve the accuracy of the statistics and add market analysis to it.
JIRA has been operating the International Technical Exhibition of Medical Imaging (ITEM). ITEM 2008 will be held for three days from April 4 - 6 at Pacifico Yokohama, which will be sponsored by the Japan Radiology Congress (JRC) and operated by JIRA.
JIRA will continue to utilize its web site and to publish “JIRA News” and the “JIRA Bulletin” and reinforce cooperation between member companies.
I have explained our main activities of last year and our priority activity policies this year.
In order to promote these activities and make them successful, along with JIRA’s own activities, it is essential to have a closer relationship with Administrative Authorities, related academic societies, and related industrial associations, etc. JIRA intends to make concerted efforts to create a “society in which people enjoy long and healthy lives” while contributing to the healthy growth of the medical imaging system industries. We appreciate your understanding and cooperation. |
